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HHS/FDA RIN: 0910-AG40 Publication ID: Fall 2010 
Title: Amendment to Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents 
Abstract: Section 102 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) requires the Secretary to publish a final rule regarding cigarettes and smokeless tobacco identical in its provisions to the regulations promulgated by FDA in 1996 (61 FR 44396, August 28, 1996) (1996 final rule), with certain specified exceptions. In the re-issued 1996 rule, 21 CFR 1140.16(a) is identical to section 897.16(a) in the 1996 final rule. Section 102(a)(3) and (4) of the FSPTCA give FDA the authority to amend the rule in accordance with the Administrative Procedure Act (5 U.S.C. Chapter 5). FDA is proposing to amend 21 CFR 1140.16(a), which became effective June 22, 2010, to allow the manufacturer of a cigarette or smokeless tobacco product with a trade or brand name that is also the trade or brand name of a nontobacco product to continue to use the name if the tobacco product was sold in the United States on or before June 22, 2009. FDA is evaluating whether further changes to 21 CFR 1140.16(a) are warranted. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1140   
Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act    PL 111-31, The Family Smoking Prevention and Tobacco Control Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/00/2011    
NPRM Comment Period End  08/00/2011    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0910-AG33 
Agency Contact:
Gail L. Schmerfeld
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFV-100, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov